Status:
ACTIVE_NOT_RECRUITING
Database Retrieval for the Comprehensive Shoulder
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis of the Shoulder
Avascular Necrosis
Eligibility:
All Genders
18+ years
Brief Summary
This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products. The primary objective of the retrieval is to collect data that will co...
Detailed Description
The Comprehensive Shoulder System has been cleared by the FDA via premarket notifications. No experimental or investigational surgical techniques or devices will be used in this study. All devices and...
Eligibility Criteria
Inclusion
- Must have one of the following indications:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
- Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
- Need to obtain pain relief and improve function
- Ability and willingness of the patient to follow instructions, including control of weight and activity level
- A good nutritional state of the patient
- The patient must have reached full skeletal maturity
Exclusion
- Absolute contraindications include infection, sepsis, and osteomyelitis.
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- Osteoporosis.
- Metabolic disorders which may impair bone formation.
- Osteomalacia.
- Distant foci of infections which may spread to the implant site.
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Key Trial Info
Start Date :
February 24 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03409718
Start Date
February 24 2011
End Date
December 1 2026
Last Update
October 30 2025
Active Locations (1)
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1
Acromion LLC
Towson, Maryland, United States, 21204